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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04269278
Other study ID # B-2002/595-301
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 12, 2020
Est. completion date December 30, 2020

Study information

Verified date June 2021
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Dexmedetomidine may alter whole blood coagulation. However, little is known about the dose-response relationships according to the blood concentration of dexmedetomidine. The investigators have therefore performed the present study to measure the effect of dexmedetomidine on the coagulation pathway according to the drug concentration level using a rotational thromboelastometry test.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date December 30, 2020
Est. primary completion date December 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - Healthy volunteers - Age: 20 to 65 years - Body weight > 50 kg - Volunteers who provided informed consent Exclusion Criteria: - Hematologic disease - Anticoagulant medication

Study Design


Intervention

Drug:
0 ul of dexmedetomidine
Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 ul) using dexmedetomidine
0.25 ul of dexmedetomidine
Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.25 ul) using dexmedetomidine
0.5 ul of dexmedetomidine
Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.5 ul) using dexmedetomidine
0.75 ul of dexmedetomidine
Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.75 ul) using dexmedetomidine

Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary FIBTEM Fibrinolytic pathway values of rotational thromboelastometry analysis/ FIBTEM is not an acronym. During the rotational thromboelastometry analysis/ an average of 1 hour
Secondary INTEM Intrinsic pathway values of rotational thromboelastometry analysis/ INTEM is not an acronym. During the rotational thromboelastometry analysis/ an average of 1 hour
Secondary EXTEM Extrinsic pathway values of rotational thromboelastometry analysis/ EXTEM is not an acronym. During the rotational thromboelastometry analysis/ an average of 1 hour
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